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Job #03090

About our client Our client is a developer of products to treat artery disease, which can occur throughout the body including the heart, neck, torso and legs. At the core of this company is a team of experts and successful medical device veterans that have developed a multi-use, proprietary catheter technology that identifies, selects and reduces atherosclerotic disease. This distinctive technology addresses the unique dynamics of arteries, utilizes well-known device procedures and does away with implants, such as a stent. The company is initially targeting Peripheral Artery Disease (PAD), "probably the most under-diagnosed and least aggressively managed" of the three vascular beds. Position Location Vice President of Regulatory Affairs San Diego, CA Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist the CEO and the Senior Management Team in formulating and implementing company strategy for Pre-Market Notifications (510ks), PMAs 2) Adapt to the dynamic, ever changing regulatory climate for medical devices 3) Ensure that the regulatory impact of new products, changes to existing products and affected processes are identified and addressed during the designing process 4) Determine regulatory impact of changes to products and services through applicable systems requiring regulatory approval 5) Interact with all personnel levels and departments to ensure full compliance with all FDA, ISO rules and regulations 6) Willingness and desire to work for a small company with startup environment 7) Ensure international and domestic labeling, website communications and clinical documentation are submitted in a timely manner and in compliance with regulatory requirements, providing regulatory guidance as needed 8) Translate proactively all FDA requirements and guidelines supplying direction and impact on products and systems 9) Manage a system to maintain and update facility registration documents and device listings at both federal and state levels in a timely manner 10) Analyze technical and business documents (e.g. regulatory documents and financial reports) 11) Read, analyze, and interpret technical and business documents (e.g. regulatory documents and financial reports), professional journals, technical procedures or governmental regulations for corporate knowledge dissemination 12) Interface with domestic and international regulatory agencies submissions, meeting requests, medical device reports and vigilance reports Requirements 1) BS/BA in Biology/Life Sciences or Chemistry, or equivalent experience with at least 10 years in FDA-regulated industry (advanced degree is preferred) 2) Minimum 10 years of experience in regulatory affairs in the medical device field 3) Experience in filing 510ks/PMAs (preferably 5 years or more) 4) Wide experience in working with the FDA 5) Experience in ISO13485/QSR 6) Willingness and desire to work for the small company with startup environment 7) Ability to write reports, business correspondence and procedure manuals 8) Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public